11 results
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18ms
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Sources: EU EUDAMED, US FDA
RIA-QUANT CK-MB TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VERTEBRIS
FDA UDI
Richard Wolf GmbH·04055207020739·TREPHINE Ø 5.3MM WL 200MM sharp, reusable
SpineWand
FDA UDI
MORGAN STEER ORTHOPAEDICS LIMITED·05060696460019·Perc DLG Convenience Pack inc 17 gauge 8” Crawf...
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004489·PERC DLG
Treace Medical Concepts (TMC) Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·May 6, 2014
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 16, 2012
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·August 11, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018